PARACETAMOL PENSA 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Pensa 650 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Paracetamol Pensa and what is it used for
2. What you need to know before you take Paracetamol Pensa
3. How to take Paracetamol Pensa
4. Possible side effects
5. Storage of Paracetamol Pensa
6. Contents of the pack and other information

1. What is Paracetamol Pensa and what is it used for

Paracetamol Pensa belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for the symptomatic treatment of mild or moderate pain and to reduce fever.

2. What you need to know before you take Paracetamol Pensa

Do not take Paracetamol Pensa

• if you are allergic to paracetamol or any of the other ingredients of this medicine.
• if you have liver disease.

Warnings and precautions

Do not take more than the recommended dose in section 3.

If the pain persists for more than 5 days (3 days for children), the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, you should stop treatment and consult a doctor.

Paracetamol Pensa should not be given to children under 6 years of age because it does not allow for dosing of amounts less than 325 mg of paracetamol per dose (half a tablet). For administration of the indicated doses in this population, other presentations should be used.

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) may cause liver damage.

In chronic alcoholics, the precaution should be taken not to take more than 2 g/day of paracetamol.

In patients with kidney, heart, or lung disease, and in patients with anemia, consult your doctor before taking the medicine.

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests that use allergens, etc...), inform your doctor that you are taking this medicine, as it may alter the results.

During treatment with Paracetamol Pensa, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medicines and Paracetamol Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

• Oral anticoagulants derived from coumarin or indandione (used for the treatment of thromboembolic diseases): may increase the anticoagulant effect.
• Anticholinergics (used for the relief of stomach, intestine, and bladder spasms or contractions): the effect of paracetamol may start later or decrease slightly.
• Contraceptives: may reduce the effect of paracetamol.
• Beta-blockers, propranolol (used for the treatment of hypertension, cardiac arrhythmias): may increase the effect of paracetamol.
• Barbiturates (used mainly as sedatives and in cases of severe insomnia): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Carbamazepine (used mainly for seizures in patients with epilepsy): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Activated charcoal (used mainly for cases of poisoning): decreases the absorption of paracetamol when administered immediately after an overdose.
• Diuretics (used to increase urine elimination): may decrease the effect of diuretics.
• Hydantoins (used in patients with epilepsy): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Isoniazid (used for the treatment of tuberculosis): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Lamotrigine (used for the treatment of epilepsy): may decrease the effect of lamotrigine.
• Probenecid (used for the treatment of gout): may slightly increase the effect of paracetamol.
• Rifampicin (used for the treatment of tuberculosis): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Sulfinpyrazone (used mainly for the treatment of gout): the effect of liver toxicity of paracetamol may increase or may decrease the effect of paracetamol.
• Zidovudine (used for the treatment of HIV infections): may decrease the effect of zidovudine.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Taking Paracetamol Pensa with food and drinks

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day - beer, wine, liquor...) may cause liver damage.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before taking any medicine.

Taking medicines during pregnancy can be dangerous for the embryo and the fetus. If you are pregnant or think you may be pregnant, consult your doctor before taking Paracetamol.

If necessary, Paracetamol Pensa can be used during pregnancy. You should use the lowest possible dose that reduces the pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Paracetamol is excreted in breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and Using Machines

No effects have been described that affect driving and using machines.

3. How to take Paracetamol Pensa

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Paracetamol. If the pain persists for more than 5 days (3 days for children), the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, you should stop treatment and consult a doctor.

Use in adults: the recommended dose for adults is half to 1 tablet (325 to 650 mg) every 4-6 hours. Do not take more than 6 tablets every 24 hours.

Use in patients with liver or kidney disease: they should consult their doctor.

Use in children and adolescents

Children under 6 years: other presentations should be used because Paracetamol Pensa 650 mg contains more than the dose that should be administered to these children.

Children from6 to11 years: the usual dose is half a tablet (325 mg), every 4-6 hours. Do not take more than 2 and a half tablets (1.625 mg) every 24 hours.

Adolescents over 12 years: the usual dose is half to 1 tablet, every 4-6 hours. Do not take more than 5 tablets every 24 hours.

Method of administration

The tablets should be taken orally with a glass of water, and if you want to administer half the dose of the tablet, it should be split at the score line.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Paracetamol Pensa than you should

If you have taken more Paracetamol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420.

If you have ingested an overdose, you should go quickly to a medical center, even if you do not have symptoms, since they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Pensa

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember and take the next doses with the indicated time interval (4-6 hours).

If you stop taking Paracetamol Pensa

Do not stop treatment before it is indicated by your doctor, as the medicine may not have the desired effect.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Pensa can cause side effects, although not everybody gets them.

Paracetamol may damage the liver at high doses or with prolonged treatment. Skin rashes and blood disorders, as well as kidney disorders, may also appear.

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Pensa

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Pensa 650 mg tablets EFG

• The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other ingredients are: povidone, potato starch glycolate, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium saccharin.

Appearance of the product and pack contents

Paracetamol Pensa 650 mg tablets are presented in the form of elongated, white, biconvex, and scored tablets. Each pack contains 20 or 40 tablets.

Marketing authorisation holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of last revision of this leaflet:January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es